3 New FSMPs for Infants Approved at the Beginning of 2019

The State Administration for Market Regulation (SAMR) has approved the registration applications of 3 FSMP products on January 24, 2019. All of the 3 products are from Nestle, the detailed information are shown in the table below:

S.N.

Applicant

Product Name

Certificate Number

Expiry Date

1

Nestlé Deutschland AG

早启能恩 preterm or low birth weight infant formula for special medical purpose

国食注字TY20195001

2024-01-23

2

Nestlé Deutschland AG

NAN H.A. partially hydrolyzed milk protein infant formula for special medical purpose

国食注字TY20195002

2024-01-23

3

NESTLE NEDERLAND B.V.

安儿宁能恩 lactose free infant formula for special medical purpose

国食注字TY20195003

2024-01-23

Summary and Analysis of the Approved FSMP in China

Until now, totally 24 FSMP products have been approved by China government. Among them, five products are domestic products while the remaining are foreign products. Relevant information are listed as below in table 1 (the newly approved products are the last 3):

Table 1. The 24 approved FSMP products

S.N.

Applicant

Product name

Certificate number

Expiry date

1

SHS INTERNATIONAL LTD

Neocate amino acid formula of infant formula powder for special medical purpose

国食注字TY20175001

2022.11.19

2

ABBOTT LABORATORIES S.A.

Similac partially hydrolyzed milk protein formula of infant formula powder for special medical purpose

国食注字TY20175002

2022.11.19

3

ABBOTT LABORATORIES S.A.

Eleva Care partially hydrolyzed milk protein formula of infant formula powder for special medical purpose

国食注字TY20175003

2022.11.19

4

HANGZHOU BEINGMATE MATERNAL AND CHILD NUTRITION CO., LTD.

Beingmate lactose free formula of infant formula food for special medical purpose

国食注字TY20180001

2023.2.12

5

SHS INTERNATIONAL LTD

Periflex phenylketonuria formula of infant formula powder for special medical purpose

国食注字TY20185001

2023.2.26

6

MEAD JOHNSON B.V.

EnfaGentlease partially hydrolyzed milk protein formula of infant formula powder for special medical purpose

国食注字TY20185002

2023.3.19

7

ABBOTT NUTRITION, ABBOTT LABORATORIES

Similac Neo preterm or low birth weight infant formula milk for special medical purpose

国食注字TY20185003

2023.6.25

8

ABBOTT NUTRITION, ABBOTT LABORATORIES

Similac Gro preterm or low birth weight infant formula milk for special medical purpose

国食注字TY20185004

2023.6.25

9

MEAD JOHNSON B.V.

Enfagrow lactose free formula of infant formula for special medical purposes

国食注字TY20185005

2023.7.22

10

NESTLE NEDERLAND B.V.

早瑞能恩 Premature or low birth weight infant formula for special medical purposes

国食注字TY20185006

2023.7.22

11

SUZHOU HENGRUI JIANKANG TECHNOLOGY CO., LTD

舒乐加 Electrolyte formula of nutritionally incomplete foods for special medical purposes

国食注字TY20180002

2023.7.22

12

SUZHOU HENGRUI JIANKANG TECHNOLOGY CO., LTD

乐棠Electrolyte formula of nutritionally incomplete foods for special medical purposes

国食注字TY20180003

2023.7.22

13

ABBOTT MANUFACTURING SINGAPORE PRIVATE LIMITED

Pediasure nutritionally complete formula

国食注字TY20185007

2023.8.2

14

MEAD JOHNSON B.V.

Enfapro premature or low birth weight infant formula for special medical purposes

国食注字TY20185008

2023.8.13

15

SYNUTRA INTERNATIONAL INC

优博敏佳Partially hydrolyzed milk protein formula of infant formula powder for special medical purpose

国食注字TY20180004

2023.8.13

16

SYNUTRA INTERNATIONAL INC

优博安能Premature or low birth weight infant formula for special medical purposes

国食注字TY20180005

2023.8.13

17

ABBOTT LABORATORIES S.A.

ABBOTT Similac preterm or low birth weight infant formula powder for special medical purpose

国食注字TY20185009

2023.10.7

18

MILUPA GMBH

Nutricia preterm or low birth weight infant formula food for special medical purpose

国食注字TY20185010

2023.10.7

19

SHS INTERNATIONAL LTD

Periflex Ad. phenylketonuria formula of nutritionally incomplete food (powder) for special medical purpose

国食注字TY20185011

2023.12.19

20

NESTLE NEDERLAND B.V.

ALFARE extensively hydrolyzed milk protein infant formula for special medical purpose

国食注字TY20185012

2023.12.19

21

ABBOTT NUTRITION

Similac HMFortifi breast milk nutrition infant formula for special medical purpose

国食注字TY20185013

2023.12.19

22

Nestlé Deutschland AG

早启能恩 preterm or low birth weight infant formula for special medical purpose

国食注字TY20195001

2024.01.23

23

Nestlé Deutschland AG

NAN H.A. partially hydrolyzed milk protein infant formula for special medical purpose

国食注字TY20195002

2024.01.23

24

NESTLE NEDERLAND B.V.

安儿宁能恩 lactose free infant formula for special medical purpose

国食注字TY20195003

2024.01.23

There are totally 8 companies obtaining FSMP registration certificates, while among the 24 products, 7 of them have been developed by one company – ABBOTT. Moreover, with the launch of the three new products, the number of approved products from Nestle has increased to 5. Meanwhile, there are 5 products developed by domestic companies -- HANGZHOU BEINGMATE MATERNAL AND CHILD NUTRITION CO., LTD, SUZHOU HENGRUI JIANKANG TECHNOLOGY CO., LTD and SYNUTRA INTERNATIONAL INC.

Food,China,Registration,Special,Medical,Purpose,Formula

Figure 1. Quantity of approved FSMP products at different companies

Among the 24 products, in terms of product type, 20 of them are infant formula for special medical purposes, 3 are nutritionally incomplete foods, and 1 is nutritionally complete food. While specific nutritionally complete food have not been approved until now. The detailed information are shown in table 2.

Table 2. Summary of the categories/types of the approved products

Categories/types

Amount being approved

Product/Company

Adapted population

FSMP for infants under the age of 12 months 

Extensively hydrolyzed milk protein formula or amino acid-based formula food

2

Neocate / SHS

ALFARE/ NESTLE

0-12 months

Partially hydrolyzed milk protein formula food

5

Eleva Care / ABBOTT

Similac / ABBOTT

EnfaGentlease / MEAD JOHNSON

优博敏佳/ SYNUTRA

NAN H.A./Nestle

0-12 months

Lactose free formula or low lactose formula food

3

Beingmate / HANGZHOU BEINGMATE

Enfagrow / MEAD JOHNSON

安儿宁能恩/ Nestle

0-12 months

Amino acid metabolism disorder formula food

1

Periflex / SHS

0-12 months

Premature or low birth weight infant formula food

8

Similac Neo / ABBOTT

Similac Gro / ABBOTT

早瑞能恩/ NESTLE

Enfapro/ MEAD JOHNSON

优博安能/ SYNUTRA

Similac/ ABBOTT

Nutricia/ MILUPA

早启能恩/ Nestle

0-12 months

Breast milk nutrition food

1

Similac HMFortifi/ ABBOTT

0-12 months

FSMP for people over the age of 12 months

Nutritionally complete foods

1

Pediasure / ABBOTT

1-10 year-old

Specific nutritionally complete foods

0

NA

NA

Nutritionally incomplete foods

Electrolyte formula

2

舒乐加/ SUZHOU HENGRUI JIANKANG

Above 10 year-old

乐棠/ SUZHOU HENGRUI JIANKANG

Above 18 year-old

Nutrient components

0

NA

NA

Thickening components

0

NA

NA

Liquid formula

0

NA

NA

Amino acid metabolism disorder formula

1

Periflex Ad./SHS

Above 10 year-old

The above information are analysis associated with the current situation of FSMP registration in China. Click to know more about FSMP registration requirements in China.

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